Severe malnutrition remains a problem for subjects receiving maintenance hemodialysis (MHD). Dialysis subjects often have poor appetites and low energy. This malnutrition is reflected in low serum albumin concentrations, a strong predictor of increased morbidity and mortality. (Moore and Lindenfield, Support Line 29(5):7-16 (October 2007)). Subjects are often treated using diet liberalization, oral supplements and enteral feeding. When these methods are not effective intradialytic parenteral nutrition (IDPN) can be utilized for more aggressive nutrition repletion efforts.
IDPN is infused during the hemodialysis procedure. IDPN has been used for decades and has resulted in weight gain and improved protein levels in subjects. (U.S. Publication No. 2005/0148647). During IDPN infusion into a subject, the subject's blood glucose must be monitored to avoid problems, such as hyperglycemia and hypoglycemia. Serum bicarbonate and carbon dioxide levels must also be monitored to check for acidosis caused by administration of amino acids.
IDPN is usually administered in one liter of solution, and occasionally micronutrients, like vitamins and minerals are co-administered in or with IDPN. Literature suggests that IDPN is effective in decreasing morbidity and mortality in hemodialysis (MHD) subjects, leads to increased levels of serum albumin and creatinine levels, and increased body weight. (Moore and Celano, Nutrition in Clinical Practice, 20(2):202-212 (2005)). Hypoglycemia is another potential dangerous result of the administration of insulin during IDPN with symptoms of nervousness, sweating, intense hunger, trembling, weakness, palpitations, and trouble speaking.
Problems associated with IDPN include hyperglycemia, complications in subjects with insulin resistance or other problems associated with glucose management, as well as complications in subjects who require strict fluid management. The glucose concentrations administered with IDPN can cause hyperglycemia and hypoglycemia in some subjects. The administration of insulin can sometimes successfully treat this hyperglycemia, but some subjects demonstrate insulin resistance, and might not respond to insulin treatment. (Goldstein and Strom, Journal of Renal Nutrition 1(1):9-22 (January 1991)). Hyperglycemia is a major barrier to effective nutrition support even outside the context of hemodialysis. Many studies report associations between hyperglycemia and increased morbidity and mortality. (McCowen and Bistrian, Nutrition in Clinical Practice, 19(3):235-244 (June 2004)). Moreover, the amount of fluid in typical IDPN treatment is a barrier to use in subjects with strict fluid management.